TW584552B - Radiofrequency thermal balloon catheter - Google Patents

Radiofrequency thermal balloon catheter Download PDF

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Publication number
TW584552B
TW584552B TW92103941A TW92103941A TW584552B TW 584552 B TW584552 B TW 584552B TW 92103941 A TW92103941 A TW 92103941A TW 92103941 A TW92103941 A TW 92103941A TW 584552 B TW584552 B TW 584552B
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Taiwan
Prior art keywords
balloon
radio
electrode
sleeve
liquid
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TW92103941A
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Chinese (zh)
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TW200416013A (en
Inventor
Shutaro Satake
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Shutaro Satake
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Priority claimed from JP2001303112A external-priority patent/JP3607231B2/en
Application filed by Shutaro Satake filed Critical Shutaro Satake
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Publication of TW584552B publication Critical patent/TW584552B/en
Publication of TW200416013A publication Critical patent/TW200416013A/en

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  • Electrotherapy Devices (AREA)

Abstract

A radiofrequency thermal balloon catheter makes it possible to heat uniformly the tissues in contact with the balloon and to achieve thermotherapy such as ablation or hyperthermia safely and properly for a diseased part. A radiofrequency thermal balloon catheter includes a catheter (4) consisting of an outer shaft (2) and an inner shaft (3) extended through the outer shaft so as to be slidable relative to the outer shaft, an inflatable balloon (6) capable of being inflated so as to be in contact with a target lesion (18) and equipped between respective front end parts of the outer and the inner shaft, a radiofrequency electrode (8) extended in a wall of the balloon or inside the balloon to be used for radiofrequency energy supply in combination with a counter electrode (53), the counter electrode being disposed at a predetermined position, for example, inside the balloon, in the wall of the balloon, in the position neighboring the balloon or on the patient's body surface, a lead wire (10) electrically connected to the radiofrequency electrode, a temperature sensor (12) capable of sensing temperature of a liquid contained in the balloon, and a temperature distribution uniformizing means such as a revolving structure (14) for uniformizing temperature distribution in the liquid contained in the balloon.

Description

584552 玖、發明說明 (發明說明應欽明:發明所屬之技術領域、先前技術、内容、實施方式及圖式簡單說明)584552 发明 Description of the invention (The description of the invention should be made clear: the technical field to which the invention belongs, the prior art, the content, the embodiments, and the illustration of the drawings)

C發明所屬技術領域;J 發明領域 本發明是有關於一種射頻式熱氣球導管(RTBC),更詳 5言之’是有關於一種射頻式熱氣球導管用以作心血管疾病 之治療。 t先前技術3The technical field to which C invention belongs; the field of J invention The present invention relates to a radio-frequency hot-air balloon catheter (RTBC). More specifically, 5 'is a radio-frequency hot-air balloon catheter for the treatment of cardiovascular diseases. t Prior Art 3

發明背景Background of the invention

使用一膨脹氣球,且藉供應射頻式能量於電極以加熱 10與氣球接觸之組織用以治療可產生射頻電場之治療方法, 揭露於如核准予本發明申請人之日本專利號2538375、 2510428及2574119。與該氣球接觸之組織必須被均勻地或 同質地加熱以滿意地達到治療法。然而,形成該電極之電 極線無法均勻地配置於該氣球内。若該電極之線被不規則 15配置時,則容納於該氣球内之液體被不規則或不同質地加 熱。容納於該氣球内之液體的局部溫度差亦會因對流及該 氣球内上部的溫度變高而增加。如此,於該氣球内分布會 無法避免地不規則或不同質。因此,於該氣球接觸之組織 無法均勻加熱。 20 【發明内容】 發明概要 據此,本發明之目的在於解決上述習知的問題,即在 提供-種射頻式熱氣球導管,可使與該氣球接觸之組織均 勻加熱,以達到溫熱療法,如安全地脫落或過高熱,且適 5 5 坎、發明說明 §地用於一害病部位。 根據本發明,-種射頻式熱氣球導管包含有··一導管 ’由-外桿及-⑽所構成,該内桿延伸穿過該外桿^ 相對於該外桿滑動,·-膨脹氣球,可膨脹⑽_目^— 損害部相關錢置於料桿㈣師的_料之^ S —射頻電極’用以與-反電極結合作射頻能量供應,延伸 =該氣球之-壁部内或該氣球内部,該反電極設置於一預 定位置,·-引線,電連接於該射頻電極;_溫度感測器, 可感測容納於該氣球内的液體之溫度;及一溫度分布均勻 化衣置,用以使容納於該氣球内的液體之溫度分布均勻化 10 該溫度分布均勾化裝置使容納於該氣球内的液體之溫 度刀布均句化,以防止容納於該氣球内的液體因對流或類 似者產生不規則溫度分布,因此與該氣球接觸之目標器官 15損害部可藉射頻加熱均勻加熱。由於容納於該氣球内的液 體中溫度分布可被均勻化,因此由該溫度感測器量測的液 體溫度可準確與該目標器官損害部的溫度一致,且因此可 精確控制該目標器官損害部的溫度。 該溫度分布均勻化裝置可為一攪動裝置,用以攪動容 20納於該氣球内的液體。該攪動裝置攪動該液體以使該液體 内的溫度分布均勻。 該射頻式熱氣球導管可進一步包括··一轉動前套管, 放置於该内桿之一前端部上,以繞該導管的軸心轉動,·一 轉動後套管,放置於該外桿之一前端部上,以繞該導管的 6 玫、發明說明 軸心轉動;及一轉動基本, 射,妒旦於j丨 s寺住该引線以致於可供應 射頻此里於该引線且該引 含數電極線,W 轉動;其中該射頻電極包 3要疋电徑羅,以相互半私 申於該轉動前套管與該轉動後 套官之間,及該攪動裝置包 瓦 3 一疑轉驅動裝置,用以驅動 该射頻電極、該轉動前套管 、 垓轉動後套官、該引線及該 轉動基本套官以使其轉動。 該攪動裝置之旋轉驅動裝 一 衣1驅動该射頻電極、該轉動 前套管、該轉動後套管、該引線及該轉動基本套管以使盆 轉動’以於射頻能量供應期間轉動該射頻電極。因此; 達到均勻的射頻能量供應, 褙Α轉勤射頻電極的攪動作 用該液體的溫度分布可均勻化。 該射頻電極包含數電極線,以相互平行連接於該轉動 前套管及該轉動後套管。因此該射頻電極可輕易形成且可 均勻地分布於該氣球内。 較佳地,形成該射頻電極之該等線性延伸電極線可被 彎曲成-圓弧形狀’以當該外桿及該内桿相互軸向移動以 使該氣球膨脹時可沿該氣球的一内表面延伸。 容納於該氣球内之該液體可藉轉動該射步員電極彎曲成 圓弧形狀之該等電極線被有效地攪動,且可產生均勻射頻 電場。 、 该引線可螺旋盤繞,且該旋轉驅動裝置可轉動該引線 以轉動該射頻電極。 當該螺旋盤繞引線被以一方向轉動時,該螺旋盤繞引 線當該旋轉驅動裝置停止轉動該螺旋盤繞引線時,可藉其 584552 玖、發明說明 本身5早性而以另一相反方向轉動以回復其自然形狀。 该旋轉驅動裝置可驅動該轉動前套管、該轉動後套管 、該引線及該轉動基本套管,以使其以相反方向交互轉動 ’:可藉於各該等相反方向預定的轉數,於轉動該轉動前 5套吕、轉動後套管、書亥引線及該轉動基本套管之後改變 該轉動前套管、該轉動後套管、該引線及該轉動基本套管 之轉動方向。因此,該射頻電極可於相反方向簡單地交互 轉動,以藉該射頻電極攪動容納於該氣球内的液體。 忒攪動裝置可包含一連接管,連接於該外桿,藉一由 1〇 4外桿與該内桿界定之通冑而與該氣球連通;震動產 生裝置,用以將震動力施予填滿於該連接管及該通道之液 體。 該震動產生裝置將震動力施予填滿於該連接管及該通 道之液體,且該等震動力被散播至容納於該氣球内的液體 15且攪動容納於該氣球内之液體以使容納於該氣球内之液體 的溫度分布均勻化。 4震動產生裝置將震動力施予填滿於該連接管及該通 道之液體,以致於使容納於該氣球内之液體中產生旋渦。 容納於該氣球内之液體中所產生之漩渦,可有效使容 20納於該氣球内之液體的溫度分布均勻化。 谷納於该氣球内之液體的溫度分布可藉該循環裝置以 一固定溫度循環該液體而使其均勻化。 該内桿延伸於該氣球内之一部位可設置數小喷嘴,且 該循環農置可包含一液體供應裝置,可供應該液體至該内 8 玖、發明說明 桿内以經由該等小喑 内 … Th射該液體且可經由該外桿及該 f I疋之4通道吸取嘴射於該氣球内之液體。 該液體供應裝置 且可經由該外桿及該 可經由該内桿之小噴嘴噴射該液體, 内桿所界定之該通道重新取得該液體 一/射頻f極可螺旋盤繞於該内桿延伸於該氣球内部之A treatment method using an inflatable balloon and supplying radio frequency energy to the electrodes to heat 10 tissues in contact with the balloon to treat a radio frequency electric field is disclosed in Japanese Patent Nos. 2538375, 2510428, and 2574119 as approved by the applicant of the present invention . The tissue in contact with the balloon must be heated uniformly or homogeneously to achieve the desired treatment. However, the electrode lines forming the electrodes cannot be uniformly arranged in the balloon. If the wire of the electrode is arranged irregularly, the liquid contained in the balloon is heated with irregularity or different texture. The local temperature difference of the liquid contained in the balloon also increases due to convection and the temperature of the upper part of the balloon becomes higher. As such, the distribution within the balloon will inevitably be irregular or heterogeneous. Therefore, the tissue contacted by the balloon cannot be heated uniformly. [Summary of the Invention] SUMMARY OF THE INVENTION Accordingly, the object of the present invention is to solve the above-mentioned conventional problems, that is, to provide a radio-frequency hot-air balloon catheter, which can evenly heat the tissues in contact with the balloon to achieve thermotherapy, If it falls off safely or is overheated, it is suitable for a diseased area when it is suitable for 5 5 bumps. According to the present invention, a radio-frequency hot-air balloon catheter includes a catheter composed of an outer rod and an outer tube, the inner rod extending through the outer rod, sliding relative to the outer rod, and an inflation balloon, Inflatable 目 目 —— The relevant part of the damage department is placed in the _ material ^ of the material pole. S — RF electrode 'is used to cooperate with the-counter electrode to supply RF energy. Extension = the wall of the balloon or the balloon. Inside, the counter electrode is arranged at a predetermined position, a lead wire is electrically connected to the radio frequency electrode; a temperature sensor that can sense the temperature of the liquid contained in the balloon; and a uniform temperature distribution, It is used to uniformize the temperature distribution of the liquid contained in the balloon. The temperature distribution uniformization device uniformizes the temperature of the liquid contained in the balloon to prevent the liquid contained in the balloon from convection. Or the like produces an irregular temperature distribution, so the damaged part of the target organ 15 in contact with the balloon can be uniformly heated by radio frequency heating. Since the temperature distribution in the liquid contained in the balloon can be uniformized, the temperature of the liquid measured by the temperature sensor can be accurately consistent with the temperature of the target organ damage portion, and therefore the target organ damage portion can be accurately controlled temperature. The temperature distribution homogenizing device may be an agitation device for agitating the liquid contained in the balloon. The agitating device agitates the liquid to make the temperature distribution in the liquid uniform. The radio-frequency hot air balloon catheter may further include a rotating front sleeve placed on a front end portion of the inner rod to rotate around the axis of the catheter, and a rotated rear sleeve placed on the outer rod. A front part is rotated around the axis of the catheter, the invention explains the axis; and a rotation is basically, shot, and envy the lead in the temple so that the lead can be supplied here and the lead contains Count the electrode wire, W rotate; wherein the RF electrode package 3 must be electrically driven, so as to semi-privately apply to each other between the rotating front sleeve and the rotating rear sleeve, and the agitation device cover 3 is driven by a suspicious rotation. A device for driving the radio frequency electrode, the rotating front sleeve, the rotating rear sleeve, the lead wire and the rotating basic sleeve to make it rotate. The rotating drive of the stirring device is equipped with a garment 1 to drive the radio frequency electrode, the pre-rotation sleeve, the post-rotation sleeve, the lead and the rotation basic sleeve to rotate the pot to rotate the radio frequency electrode during the supply of radio frequency energy. . Therefore, to achieve a uniform RF energy supply, the stirring action of the 褙 Α transfer radio frequency electrode can be uniformized with the temperature distribution of the liquid. The radio frequency electrode includes several electrode wires to be connected in parallel to the pre-rotating sleeve and the post-rotating sleeve. Therefore, the RF electrode can be easily formed and can be evenly distributed in the balloon. Preferably, the linearly extending electrode wires forming the radio frequency electrode may be bent into a circular arc shape so that when the outer rod and the inner rod move axially with respect to each other to expand the balloon, they may be moved along an inner portion of the balloon. Surface extension. The liquid contained in the balloon can be effectively agitated by rotating the shooter electrodes to bend the electrode wires into an arc shape, and can generate a uniform radio frequency electric field. The lead wire can be spirally wound, and the rotation driving device can rotate the lead wire to rotate the radio frequency electrode. When the spirally wound lead is rotated in one direction, when the rotary drive device stops rotating the spirally wound lead, it can be rotated in the opposite direction to recover by its 584552 玖, invention description itself 5 Its natural shape. The rotary driving device can drive the pre-rotating sleeve, the post-rotating sleeve, the lead wire and the turning basic sleeve so that they rotate in opposite directions alternately: a predetermined number of revolutions can be borrowed by each of these opposite directions, After rotating the five sets of lube before the rotation, the sleeve after the turning, the lead wire of the book and the rotating basic sleeve, the rotation directions of the sleeve before the turning, the sleeve after the turning, the lead and the rotation basic sleeve are changed. Therefore, the radio frequency electrode can be simply rotated in opposite directions to agitate the liquid contained in the balloon by the radio frequency electrode. The agitation device may include a connecting tube connected to the outer rod and communicated with the balloon by a passage defined by the 104 outer rod and the inner rod; a vibration generating device for applying a vibration force to fill the The connecting tube and the liquid in the channel. The vibration generating device applies a vibration force to the liquid filled in the connecting pipe and the channel, and the vibration force is spread to the liquid 15 contained in the balloon and agitates the liquid contained in the balloon to be contained in the balloon. The temperature distribution of the liquid in the balloon is uniform. 4 The vibration generating device applies a vibration force to the liquid filling the connecting pipe and the channel, so that a vortex is generated in the liquid contained in the balloon. The vortex generated in the liquid contained in the balloon can effectively uniformize the temperature distribution of the liquid contained in the balloon. The temperature distribution of Guna's liquid in the balloon can be made uniform by circulating the liquid at a fixed temperature by the circulation device. The inner rod can be provided with a number of small nozzles in a part of the balloon, and the circulating farm can include a liquid supply device for the liquid to be supplied to the inner 8 玖, invention description rod to pass through the small 喑… Th shoots the liquid and can shoot the liquid in the balloon through the outer rod and the 4-channel suction channel of the f I 疋. The liquid supply device can spray the liquid through the outer rod and the small nozzle that can pass through the inner rod, and the channel defined by the inner rod reacquires the liquid- / RF f pole can be spirally coiled around the inner rod and extends to the Inside the balloon

▲ I5位®此,该射頻電極可輕易地設置於該氣球内用以 向效率射頻加熱。 該氣球可以抗灰栓形成(antithr〇mb〇genic)、妖 10性樹脂所形成。該氣球可適意符合所有必須特質Γ疋 顧疋位置可為於病人身體上的一位置,且該反電極 是附著於病人身體上。 垓預疋位置可為於該氣球的一壁部内或該氣球内部之 一位置。 15 該預定位置可為鄰近於該氣球之一位置。▲ I5 position® This RF electrode can be easily placed inside the balloon for efficient RF heating. The balloon can be formed of antithrombogenic and demonogenic resin. The balloon can conform to all the necessary characteristics. The position can be a position on the patient's body, and the counter electrode is attached to the patient's body. The 垓 pre- 疋 position may be a position within a wall portion of the balloon or inside the balloon. 15 The predetermined position may be a position adjacent to the balloon.

圖式簡單說明 本發明之上述及其他目的、特徵及優點將由以下詳細 說明,並配合參考圖式而得以瞭解,其中·· 第1圖是根據本發明第一實施例的射頻式熱氣球導管 2〇 —前部之示意透視圖; 第2圖是該射頻式熱氣球導管連續於第丨圖所示的射 頻式熱氣球導管前部之後部之示意透視圖; 第3圖是用以說明該射頻式熱氣球導管於應用於作心 房纖維顫動治療的肺血管之電隔離的操作之示意圖; 9 584552 玖、發明說明 第4⑷及4(b)圖是—氣球導管的示意圖,分別是於該 氣球被壓縮用以插入於肺血管内的狀態,及㈣氣球_ 以與一目標器官損害部接觸的狀態; 第5圖是根據本叙明第二實施例的射頻式熱氣球導管 5 之示意透視圖; 第6⑷及6(b)圖是第5圖所示該射頻式熱氣球導管的 示意圖,分別是於-氣球被壓縮用以插入於股動脈内的狀 態,及於該氣球膨脹以與一目標組織鄰近處接觸的狀態; 第圖疋用以•兒B月—熱氣球導管用於治療動脈硬化症 10 的使用之示意圖;及 之部分圖。 Ϊ:實施方式】 較佳實施例之詳細說明 15 20 —根據本發明第-實施例中之射頻式熱氣球導管將參考 ^ 4圖$述之。如弟丨及2圖所示,—種射頻式熱氣 Ά ^ 1包3 "~導官4 ’其由—外桿2及延伸於該外桿2 内以相對於該外桿2滑動之-内桿3所構成,-可膨脹氣 球6’其可膨脹以與一目標器官損害部接觸且延伸於該外 桿2與内桿3的端部之間,—射頻電極8設置於該氣球6 内,—引線H),其電連接於該射頻電極8,一熱電偶^放 置於該氣球6内且可感應該氣球6内的溫度,及一授動裝 置⑷即-溫度分布均勾化裝置,用以使容納於該氣球: 内的液體溫度均勻分布。一導線16延伸穿過該内 10 玖、發明說明 上與4導官4同軸。該導線16導引該導管4。 —二7動前套管2G放置於該崎3延伸於錢球6内之 放:==以繞:導管4的軸心轉動。-轉動後套管21 。士…干2之一前端部上用以繞該導管*的軸心轉動 二=頻電極8包含數電極線8a以相互平行延 則套管如與該轉動後套管21之間。該射頻電極8之^ 線8a當錢球6被壓料,以實質上線性延伸。當該 6错料桿2相對於該内桿3滑動而膨脹時, …曲成-圓弧形狀,以沿該氣球6内表面延伸,:: 10 1圖所不。 -轉動基本套管23放置於該内桿3上以繞該導管4的 轴心轉動於近該外桿2後端的位置處。該轉動基本套管23 具有一前端部設置有-環體24、—後端部設置有_接觸環 15 20 M、及-中間部設置有—齒輪26一支撑於_集電弓上: 電刷29保持與該接觸環25接觸。 一外螺紋31形成於該外桿2的一後端部上。一螺帽 32與:外螺紋31螺接。〇型環27放置於該轉動基本套J 23以密封該外桿2絲面與該轉動基本套管u外表面之 間的間隙而形成一水密型式。因此該轉動基本套管Μ與該 外桿2之間的間隙,及該轉動基本套管23與該内桿3之間 的間隙被密封成一水密型式 套管20、該轉動後套管21 。該内桿3延伸穿過該轉動前 及该轉動基本套管23。一外螺 紋33形成於該轉動基本套管23的一後端部上,且一螺帽 34與該外螺紋33螺接。—〇型環28㈣該内桿3外表面 11 584552 玖、發明說明 與該轉動基本套管23内表面之間的間隙形成一水密型式。 «亥引線1 〇呈螺旋狀盤繞。該引線丨〇使其一端連接於 轉動後套笞21 ’其另一端連接於該接觸環25。與該接觸 環25保持接觸之該電刷29電連接於一射頻產生器4〇。由 5該射頻產生器40產生的射頻能量經由該引線10供應於該 射頻電極8。該射頻產生器供應13·56ΜΗζ的射頻電流於該 射v員電極8與一附接於病人身體表面上的反電極μ (第3 圖)之間。舉例來說,當該氣球6的直徑約為2.5cm時供 應具100至200W輸出的射頻能量予該射頻電極8。當射 1〇頻電流供應於該射頻電極8與附接於病人身體表面上的該 反電極53之間時,與該氣球6接觸之組織18藉附有射頻 電’丨貝加熱之電容型式加熱而被燒灼。該電介質加熱是於 該氣球6内部環繞該電極8且與不同電介質常數成比例的 產生。因此,與該氣球6接觸之該等組織18被燒灼是根據 15射頻加熱的原理,即熱是分別具有不同電介質常數之電介 質構件的接觸部上產生。 一具有齒輪36及37與一馬達38之減速齒輪35設置 近於該齒輪26。該馬達38的輸出軸的旋轉經由該等齒輪 36及37傳送一較低速度於該齒輪26。該馬達38可被控制 20使其輸出軸以於單一方向之預定轉數的方式旋轉,或可被 控制使其輸出軸以於順時針方向二滿轉數及於反時針方向 二滿轉數交互的方式旋轉。 該引線10係以稍微堅硬材質形成。當該馬達38驅動 固定於該齒輪26之該轉動基本套管23時,連接於該環體 12 玖、發明說明 24之該引線1 〇被轉動,且因此,該轉動後套管21、該射 頻電極8及該轉動前套管2〇可被轉動。 當該馬達38被控制以使該引線1〇以單一方向轉動一 預定轉數時,該引線1〇以與該引線10螺旋盤繞的方向相 5反的方向轉動。當該馬達3δ於轉動該引線10 —預定轉數 之後止日守,该引線1 〇會以相反方向自動轉動以回復其原 來形狀。該射頻電極8可藉交互起動及停止該馬達38而以 相反方向父互轉動。當該馬達38被控制使其輸出軸以於順 .時針方向二滿轉數及於反時針方向二滿轉數交互旋轉時, 0遠引線ίο係以彈性材質形成_平直形狀以使該射頻電極8 以相反方向交互轉動。 15 20The drawings briefly explain the above and other objects, features, and advantages of the present invention by the following detailed description, which will be understood with reference to the drawings, in which ... FIG. 1 is a radio-frequency hot-air balloon catheter 2 according to a first embodiment of the present invention 〇—a schematic perspective view of the front part; FIG. 2 is a schematic perspective view of the radio frequency hot air balloon catheter continuously behind the front part of the radio frequency hot air balloon catheter shown in FIG. 丨; FIG. 3 is a diagram for explaining the radio frequency Schematic diagram of the operation of the hot-air balloon catheter used in the electrical isolation of pulmonary blood vessels for atrial fibrillation treatment; 9 584552 (4) and 4 (b) of the invention description are the schematic diagrams of the balloon catheter, which are The state of being compressed for insertion into a pulmonary vessel, and the state of the balloon in contact with a target organ lesion; FIG. 5 is a schematic perspective view of a radio-frequency hot-air balloon catheter 5 according to the second embodiment of the present description; Figures 6 (b) and 6 (b) are schematic diagrams of the radio-frequency hot-air balloon catheter shown in Figure 5, respectively, in a state where the balloon is compressed for insertion into the femoral artery, and when the balloon is inflated to meet a target In contact adjacent the knitting; FIG piece goods for the first month • child B - schematic diagram of a heat treatment using the balloon catheter 10 of arteriosclerosis; and a portion of the FIG. Ϊ: Embodiment] Detailed description of the preferred embodiment 15 20 —The radio-frequency hot-air balloon catheter according to the first embodiment of the present invention will be described with reference to FIG. 4. As shown in Figure 丨 and Figure 2, a kind of radio-frequency hot gas Ά ^ 1 pack 3 " ~ Guide 4 'It consists of-the outer rod 2 and extending inside the outer rod 2 to slide relative to the outer rod 2- The inner rod 3 is composed of an inflatable balloon 6 ′ which is inflated to contact a target organ damage and extends between the outer rod 2 and the end of the inner rod 3. A radio frequency electrode 8 is arranged in the balloon 6. --- lead wire H), which is electrically connected to the radio frequency electrode 8, a thermocouple ^ is placed in the balloon 6 and can sense the temperature in the balloon 6, and an actuating device, namely, a temperature distribution uniformization device, Used to evenly distribute the temperature of the liquid contained in the balloon :. A wire 16 extends through the inner part 10, and the description of the invention is coaxial with the four guides 4. The guide wire 16 guides the catheter 4. — 2 7 The front sleeve 2G is placed in the saki 3 and extends inside the money ball 6 Put: == to rotate around: the axis of the catheter 4. -Turn the rear sleeve 21. Taxi ... One of the front ends of the stem 2 is used to rotate around the axis of the catheter *. The two-frequency electrode 8 includes a number of electrode wires 8a extending parallel to each other, such as between the sleeve and the sleeve 21 after the rotation. The wire 8a of the radio frequency electrode 8 extends substantially linearly when the money ball 6 is pressed. When the 6 mismatched rod 2 slides and expands relative to the inner rod 3,… is curved into an arc shape to extend along the inner surface of the balloon 6: 10 1 not shown in the figure. -Rotating the basic sleeve 23 is placed on the inner rod 3 to rotate about the axis of the catheter 4 near the rear end of the outer rod 2. The rotating basic sleeve 23 has a front end provided with a ring body 24, a rear end provided with a contact ring 15 20 M, and a middle portion provided with a gear 26 supported on a pantograph: electric brush 29 is in contact with the contact ring 25. An external thread 31 is formed on a rear end portion of the external rod 2. A nut 32 is screwed with the external thread 31. The o-ring 27 is placed on the rotating basic sleeve J 23 to seal the gap between the wire surface of the outer rod 2 and the outer surface of the rotating basic sleeve u to form a watertight type. Therefore, the clearance between the rotating basic sleeve M and the outer rod 2 and the clearance between the rotating basic sleeve 23 and the inner rod 3 are sealed into a watertight type sleeve 20 and the rotated sleeve 21. The inner rod 3 extends through the pre-rotation and the rotation basic sleeve 23. An external thread 33 is formed on a rear end portion of the rotating basic sleeve 23, and a nut 34 is screwed to the external thread 33. —O-ring 28㈣The outer surface of the inner rod 3 11 584552 玖, description of the invention and the gap between the inner surface of the rotating basic sleeve 23 forms a watertight type. «亥 Lead 10 is spirally coiled. One end of the lead wire is connected to the rotating sleeve 21 'and the other end is connected to the contact ring 25. The brush 29, which is in contact with the contact ring 25, is electrically connected to a radio frequency generator 40. The radio frequency energy generated by the radio frequency generator 40 is supplied to the radio frequency electrode 8 through the lead 10. The radio frequency generator supplies a radio frequency current of 13.56 Μ 于 ζ between the radio frequency electrode 8 and a counter electrode μ (Fig. 3) attached to the surface of the patient's body. For example, when the diameter of the balloon 6 is about 2.5 cm, radio frequency energy of 100 to 200 W is supplied to the radio frequency electrode 8. When a radio frequency 10 current is supplied between the radio frequency electrode 8 and the counter electrode 53 attached to the surface of the patient's body, the tissue 18 in contact with the balloon 6 is heated by a capacitor type of radio frequency heating. And was burned. The dielectric heating is generated around the electrode 8 inside the balloon 6 and is proportional to different dielectric constants. Therefore, the tissues 18 in contact with the balloon 6 are cauterized according to the principle of RF heating, that is, heat is generated on the contact portions of the dielectric members having different dielectric constants, respectively. A reduction gear 35 having gears 36 and 37 and a motor 38 is disposed close to the gear 26. The rotation of the output shaft of the motor 38 transmits a lower speed to the gear 26 via the gears 36 and 37. The motor 38 can be controlled 20 so that its output shaft rotates with a predetermined number of revolutions in a single direction, or it can be controlled so that its output shaft interacts with two full revolutions in the clockwise direction and two full revolutions in the counterclockwise direction. Way to rotate. The lead 10 is formed of a slightly hard material. When the motor 38 drives the rotating basic sleeve 23 fixed to the gear 26, the lead wire 10 connected to the ring body 12 玖, invention description 24 is rotated, and therefore, the sleeve 21, the radio frequency after the rotation The electrode 8 and the sleeve 20 before the rotation can be rotated. When the motor 38 is controlled to rotate the lead wire 10 in a single direction by a predetermined number of revolutions, the lead wire 10 is rotated in a direction opposite to the direction in which the lead wire 10 is spirally wound. When the motor 3δ is closed after turning the lead wire 10 by a predetermined number of revolutions, the lead wire 10 will automatically rotate in the opposite direction to restore its original shape. The radio-frequency electrode 8 can rotate and rotate the motor 38 in opposite directions by alternately starting and stopping the motor 38. When the motor 38 is controlled to rotate its output shaft clockwise with two full revolutions in the clockwise direction and counterclockwise with two full revolutions, the 0 far lead is made of an elastic material and has a flat shape to make the radio frequency. The electrodes 8 alternately rotate in opposite directions. 15 20

«動裝置14,即_溫度分布均勻化裝置,包含該轉 動前套管20、該轉動後套管2卜該轉動基本套管Μ及該 馬達38,以轉動該射頻電極8。該引線1G將該馬達38的 旋轉驅動力傳送於該射頻電極8,且將由該射頻產生器4〇 產生的射頻能量傳送於該射«極8。·動裝置Μ用以 減除產生於心球6内的局部溫度差,且該授動裝置Μ使 該氣球6内部液體的溫度分布均勻。 接於該外桿2之-後端部。該分3 ^設置有-通氣管及—對比劑供應管。該分支t 51 ^ 亂官被打開以使該氣球6妯* 徘乳,且之後其對比劑供應, 打開以供應液體,例如生 玍理艮鹽溶液,供應於該氣球6 以將該氣球6膨脹。 該内桿3設置有 二内腔,即第一及第二内腔 該第一 13 584552 玖、發明說明 内腔是使用作為用以延伸該導線16的空間及用於液體的通 迢。該第二内腔是使用作為用以延伸導體的空間,該導體 用以傳送由附接於該内桿3露出段的中間部的該熱電偶η 所提供之訊號。 5 容納於該氣球6内之液體的溫度是以附接於該内桿3 之熱電偶12量測。該熱電偶12的導體延伸穿過該内桿3 的第二内腔,且連接於一溫度計42。該溫度計42指示容 納於該氣球6内之液體的溫度。 該氣球6係以熱阻、撓性、抗血栓形成 1〇 (antithr〇mb〇genic)樹脂所形成。於一膨脹狀態時,該氣球 6具有一類似洋蔥頭形狀,如第1圖所示。 該射頻電極8包含該等數電極線8a。該等電極線8a 的數目是幾個至幾十個的範圍中。當該内# 3相對於該外 桿2軸向移動以減少該轉動前套管2〇與該轉動後套管幻 15之間的區間時’該等實質上線性電極線8a被彎曲成圓弧形 狀’以致於該射頻電極8呈現大致類似籃子或洋蔥頭的形 狀若°亥等弘極線8a以形狀記憶合金所形成,該等電極線 8a可精確改變其形狀於實質上線性形狀與圓弧形狀之間。 該等電極線8a的前及後端部被覆有樹脂,以防止該等電極 20線8a的前及後端部之過度射頻加熱。 該射頻產生器40供應在兆赫等級上的射頻電力,例如 13·56ΜΗζ,至该射頻電極8。藉此,熱可藉電容射頻加熱 於病人身體一部位而產生於該射頻電極8與附接於病人背 部表面的反電極53之間,如第3圖所示。 14 10 15 20 玖、發明說明 該射頻電極8藉該螺旋引線10連接於該轉動基本套管 23的接觸環25。切於集電弓上謂接於該射頻產生器 4〇之該電刷29保持與該接觸環25接觸以將射頻能量供應 至该射頻電極8。該射頻雜8被轉動以產生更進一步均 勻的射頻電場繞於該射頻電極8。 该減速齒輪35減低輪人速度,即該馬達%輸出抽的 旋轉速度,成較低輸出速度。該馬達38的旋轉力被經由該 減速齒輪35、該齒輪26傳送至該轉動基本套# 23。該轉 動土本套| 23的方疋轉藉該引線五Q傳送至該轉動後套管2叉 以轉動該氣球6内之電極線8a。因此,填滿於該膨服氣球 6内之液體被料電極線6a㈣,以防止因對流之不規則 的’皿度刀布及使填滿於該氣球6的液體的溫度均勻化分布 。因此,於該氣球6的中央區域内之液體的溫度、於該氣 球6壁部鄰近處之液體的溫度,及於與該氣球6接觸的組 織18之溫度可均等。因此,於該氣球6的中央區域内之液 體,以該熱電偶12量測且以該溫度計42指示之溫度,可 精確代表與該氣球6接觸的組織之溫度。 時 。亥液月且的/皿度疋當该射步員能量被供應於該射頻電極$ 以設置於該内桿3露出段内之該熱電偶12量測而得,且 X射頻產生為40的輸出是以一反饋控制模式控制以致於填 滿於該紐6的液體可於1佳溫度加熱H與㈣ 球6接觸的組織18可於一最佳溫度加熱。 該轉動籃狀射頻電極8 動填滿於該氣球6的液體。 產生一更均勻射頻電場,且攪 因此,於該液體内的溫度分布 15 玖、發明說明 可均勻且與該氣球6接觸的組織18可精讀加熱於所要溫度 0 茲將詳細說明該射頻式熱氣球導管丨的操作情形,其 應用於肺A管之電隔離以作心房纖維顫動之治療。 5 第3圖是用以解釋說明燒灼環繞於肺血管17的毛孔 W之心房19的組織18之作動。將生理食鹽溶液通過該 外桿2的分支管51供應於該氣球6内及將生理食鹽溶液吸 到該氣球6外之循環重覆幾次以淨化該氣球6的空氣。如 第4(a)圖所示,該氣球6被壓縮且該内桿3被自該外桿2 1〇完全伸出,以致於該轉動前套管20與該轉動後套管21之 Η的距離立曰加至一限度,且該射頻電極8的電極線於將 該射頻式熱氣球導管1插入於肺血管17内之前,以實質上 線性延伸。於此狀態,該氣球6的直徑降低至最低。然後 ,該氣球6被插入於肺企管17内。操作該射頻式熱氣球導 15管1以將該氣球6安置於近該等目標組織18。然後,如第 4(b)圖所示,撤出該内桿3,將對比劑及生理食鹽溶液經由 邊分支官51供應於該氣球6内以將該氣球6膨脹。由於該 轉動前套管20被移動向該轉動後套管21,因此該等電極 線8a被彎曲成圓弧形狀。藉此,該射頻電極8被以籃子形 2〇狀伸展於該氣球6内。該射頻式熱氣球導管i持續地操作 以使該氣球6與該等目標組織μ接觸。 之後,起動該馬達38以驅動該轉動基本套管23用以 藉由該減速齒輪35轉動。該轉動基本套管23的轉動力藉 延伸穿過該導管4之該螺旋引線1〇被傳送至該轉動後套管 16 584552 玖、發明說明 21°因此’以籃子形狀伸展於該氣球6内之該射頻電極8 破轉動以攪動填滿於該氣球6内的液體。 ίο 15 隨後’該射頻產生器40將一射頻電流,如13·56ΜΗζ 的射頻電机,應用於附著於病人背部之該反電極^,與連 ;接於該射頻式熱氣球導管i以籃子形狀伸展之該射頻電極 的接觸% 25之間。一射頻電流流經該電刷29以與該接 觸% 25接觸。因此,該氣球6及與該氣球6接觸之該等组 =18被附有射頻電介質加熱之電容型式加熱而被加熱。僅 管於該氣球6内一上區域的溫度,若容納於氣球6内的液 體不被撥動時會因對流而較該氣球6内一下區域為高,容 納於該氣球6内之液體的溫度分布,可因藉以藍子:狀伸 展的該轉動射頻電極8來撥動該液體而均勾。若該射頻電 極8不與該氣球6對準且固持於該氣球6内,則該等組織 18會被不規則加熱。由於該射頻電極8被加熱,因此可產 生-均勻射頻電場環繞於該射頻電極8,且該氣球6及該 等組織18藉射頻加熱而均勻地加熱。 該氣球6近該等轉動套管2〇及21供該等電極線以聚 集環繞的部分具有-過熱傾向。如此過熱可藉使該等轉動 20 套管20及21以具有小電介質常數的材質形成來避免,例 如樹脂或陶究材質,及/或藉在該等電極線^的部位被覆 有樹脂來避免,及/或藉循環冷卻水通過該内桿3來避免。 因此,肺血管17可藉燒灼該心房19繞於肺企管17的 環形部位之組織18而被電隔離,以對病人作纖維顏動 之安全治療。 17 584552 坎、發明說明 〜根據本發明-第二實施例之射頻式熱氣球導管1詳述 於后。該射頻式熱氣球導管丨包 匕3循核系統60用以循環 : 氣球6内的液體以使液體溫度分布均勾化。一内 柃3延伸於該氣球6内的部分設置有數小噴嘴該循環 66用以使—液體保持被供應於 乂内才干3内’例如37 c的液體,及一液體供應裝置62,可 ίο 15 將受該溫度控制器66控制之預定溫度的液體供應於該内桿 3内,且可將喷射通過該等小噴嘴64之液體經由該内桿3 與-外桿2之間的環形空間吸人該氣球6内。當 膨脹時,該氣球6具有-橢圓球形狀。一射頻電極8繞該 内桿3延伸於該氣球6内的部位螺旋盤繞。該射頻電極8 藉-引線H)連接於-射頻產生!4Ge容納於該氣球6内 的液體之溫度係以一熱電偶12所量測,且以相似於上述第 一實施例的方法監控,且用以供應於該射頻電極8的射頻 能量係根據所量測的溫度來控制。 如第5圖所示,受該溫度控制器66控制於例如37t: 之一循環液體70被於44°C加熱,而同時該循環液體7〇流 經該内桿3延伸於該氣球6内的部位且喷射通過該等小嗔 嘴64而流入該氣球6内。噴射於該氣球6内的該循環液體 20 70之溫度掉至43.5°C且當該循環液體70到達該外桿2前 端時再進一步掉至43°C。藉此該循環液體70被該循環系 統60循環以使容納於該氣球6内的液體均勻地保持在約 43.5〇C。 以下洋細5兒明如弟5圖所不之射頻式熱氣球導管1將 18 584552 玖、發明說明 應用於動脈應用部位之藥物治療上,如第7圖所示。 5 10 15 該射頻式熱氣球導管1的氣球6被壓縮,且該射頻 熱氣球導管1插穿於頸動脈的害病部位68内股動脈,如^ 6(a)圖所不。然後,一對比劑及一生理食鹽溶液供應通過 -附接料外桿2上的分支f 51而供應於該氣球㈣。因 此,該氣球6膨脹以伸展該害病部位⑼的狹窄部位,如第 6⑻圖所示。於此狀態時,起動施—13.;6mHz的射頻電壓 橫過該射頻電極8及附著於病人背部的反電極53。 ^該循環系統60藉加壓將例如3rc之循環液體%供應 於》亥内# 3的内腔内。被射頻加熱之該循環液體爪被喷射 穿過該等小噴嘴64而噴人該氣球6内。該循環液體%流 經該氣球6’以使該氣球6内均勻化溫度分布,且被放出 通過該外桿2的内腔。當該氣球6被維持在43沈2〇分鐘 或更久時,頸動脈的動脈粥樣硬化損害部位68内之發炎性 細胞或增生平滑肌細胞會騎計触細胞壯(ap_is), 且頸動脈之動脈粥樣硬化損害部位68可穩定。之後,該氣 球6被壓縮,且該射頻式熱氣球導管丨自股動脈撤出。 該射頻式熱氣球導管!可於一最佳溫度下均句地加熱 害病部位68 m因此,頸動脈的動脈粥樣硬化損害部 20位68可經由該等發炎性細胞或增生平滑肌細胞之巨嘆細胞 即不安疋因子之計劃性細胞凋亡(ap〇t〇sis)而可穩定化, 其是藉將頸動脈的動脈粥樣硬化損害部位6W 43 5〇c加熱 2〇分鐘或更久,而不會影響正常組織,例如内皮。 。亥射頻式熱氣球導管丨可應用於癌症之過高熱 19 584552 玖、發明說明 (hyperthermia)。事實證明癌症細胞可藉將其加熱於43.5°C 20分鐘或更久而被控制或根絕。 如第8圖所示是顯示根據本發明第三實施例的射頻式 熱氣球導管1,該射頻式熱氣球導管1包含一氣球6及一 5 攪動裝置80,用以攪動容納於該氣球6内的液體至使該液 體的溫度分布均勻化。 該攪動裝置80包含一連接管82連接於一外桿2以開 放形成一以該外桿2所界定之環形通道83 ,及一内桿3延 伸通過該外桿2,及一震動產生器81,例如一震動產生隔 10板泵,以施震動力至填滿於該環形通道83内之液體。該連 接管82藉由該環形通道83與該氣球6相連通。由該震動 產生器81產生如約1Hz的震動力86經由填滿於該連接管 82與該環形通道83的液體散播。因此,容納於該氣球6 内的液體會因該授動液體與重力之間互動而產生旋渴85。 15這些旋渴經由運行中不定方向授動該液體,以致於容納於 該氣球6内之液體的溫度分布可均句化。藉此,形成於該 等組織68内的粉瘤可於一最佳溫度被同質加熱。 與第5圖所示的射頻電極8相似,螺旋盤繞於該内桿 3之一射頻電極8是用以射頻加熱。 20 #該氣球6是以適意撓性材質形成時,藉以該震動產 生器81所產生的震動力86’可使容納於該氣球6内的液 體中產生適度漩渦。 由前述可知’本發明之射頻式熱氣球導管可藉射頻加 熱於-最佳溫度均句加熱與該氣球相接觸的組織,且可安The moving device 14, that is, the temperature distribution homogenizing device, includes the pre-rotating sleeve 20, the post-rotating sleeve 2, the turning basic sleeve M, and the motor 38 to rotate the radio frequency electrode 8. The lead wire 1G transmits the rotational driving force of the motor 38 to the radio frequency electrode 8, and transmits radio frequency energy generated by the radio frequency generator 40 to the emitter electrode 8. The moving device M is used to reduce the local temperature difference generated in the heart ball 6, and the moving device M makes the temperature distribution of the liquid inside the balloon 6 uniform. At the rear end of the outer rod 2. The minute 3 is provided with a -ventilation tube and a contrast agent supply tube. The branch t 51 ^ messenger is opened to make the balloon 6 妯 milk, and then the contrast agent is supplied, and opened to supply a liquid, such as raw salt solution, to the balloon 6 to expand the balloon 6 . The inner rod 3 is provided with two inner cavities, that is, a first and a second inner cavity. The first 13 584552 玖, description of the invention The inner cavity is used as a space for extending the lead 16 and as a fluid passage. The second inner cavity is used as a space for extending a conductor for transmitting a signal provided by the thermocouple η attached to a middle portion of the exposed section of the inner rod 3. 5 The temperature of the liquid contained in the balloon 6 is measured with a thermocouple 12 attached to the inner rod 3. The conductor of the thermocouple 12 extends through the second inner cavity of the inner rod 3 and is connected to a thermometer 42. The thermometer 42 indicates the temperature of the liquid contained in the balloon 6. The balloon 6 is made of a thermally resistant, flexible, antithrombogenic resin. In an inflated state, the balloon 6 has an onion-like shape, as shown in FIG. 1. The radio frequency electrode 8 includes an equal number of electrode lines 8a. The number of such electrode wires 8a is in the range of several to several tens. When the inner # 3 is moved axially relative to the outer rod 2 to reduce the interval between the pre-rotation sleeve 20 and the post-rotation sleeve 15, the substantially linear electrode wires 8a are bent into an arc Shape ', so that the RF electrode 8 has a shape similar to a basket or onion head. If the Hongji wires 8a such as Hai are formed of a shape memory alloy, the electrode wires 8a can precisely change their shape to a substantially linear shape and an arc. Between shapes. The front and rear ends of the electrode wires 8a are covered with resin to prevent excessive radio-frequency heating of the front and rear ends of the electrode wires 8a. The radio frequency generator 40 supplies radio frequency power on the megahertz level, for example, 13.56 MHz to the radio frequency electrode 8. Thereby, heat can be generated by a capacitor RF to a part of the patient's body and generated between the RF electrode 8 and the counter electrode 53 attached to the back surface of the patient, as shown in FIG. 14 10 15 20 发明. Description of the invention The radio frequency electrode 8 is connected to the contact ring 25 of the rotating basic sleeve 23 through the spiral lead 10. The brush 29, which is cut on the pantograph, is said to be connected to the radio frequency generator 40. The brush 29 is kept in contact with the contact ring 25 to supply radio frequency energy to the radio frequency electrode 8. The radio frequency antenna 8 is rotated to generate a more uniform radio frequency electric field around the radio frequency electrode 8. The reduction gear 35 reduces the speed of the driver, that is, the rotation speed of the motor's% output, to a lower output speed. The rotational force of the motor 38 is transmitted to the rotating basic sleeve # 23 via the reduction gear 35 and the gear 26. The square box of the rotating earthen sleeve | 23 borrows the lead wire 5Q and transfers it to the rotating sleeve 2 fork to rotate the electrode wire 8a in the balloon 6. Therefore, the liquid-filled electrode wire 6a㈣ filled in the inflatable balloon 6 is used to prevent the irregular 'knives' due to convection and to make the temperature of the liquid filled in the balloon 6 uniform. Therefore, the temperature of the liquid in the central region of the balloon 6, the temperature of the liquid near the wall portion of the balloon 6, and the temperature of the tissue 18 in contact with the balloon 6 can be equal. Therefore, the temperature of the liquid in the central area of the balloon 6 measured by the thermocouple 12 and indicated by the thermometer 42 can accurately represent the temperature of the tissue in contact with the balloon 6. Time . The value of the helical fluid is measured when the energy of the shooter is supplied to the RF electrode $, and the thermocouple 12 set in the exposed section of the inner rod 3 is measured, and the X RF produces an output of 40 It is controlled in a feedback control mode so that the liquid filled in the button 6 can be heated at a good temperature. The tissue 18 in contact with the bulb 6 can be heated at an optimal temperature. The rotating basket-shaped RF electrode 8 is filled with the liquid of the balloon 6. Generate a more uniform radio frequency electric field and stir the temperature distribution in the liquid 15 玖, the description of the invention that the tissue 18 that can be uniform and in contact with the balloon 6 can be intensively heated to the desired temperature 0 The radio frequency hot air balloon will be explained in detail The operation of the catheter is applied to the electrical isolation of the pulmonary A tube for the treatment of atrial fibrillation. 5 FIG. 3 is a diagram for explaining the action of cauterizing the tissue 18 of the atrium 19 surrounding the pores W of the pulmonary blood vessel 17. The physiological salt solution is supplied into the balloon 6 through the branch tube 51 of the outer rod 2 and the circulation of the physiological salt solution outside the balloon 6 is repeated several times to purify the air of the balloon 6. As shown in FIG. 4 (a), the balloon 6 is compressed and the inner rod 3 is fully extended from the outer rod 2 10, so that the rotation of the sleeve 20 before the rotation and the sleeve 21 after the rotation The distance is increased to a limit, and the electrode wire of the radio frequency electrode 8 extends substantially linearly before the radio frequency hot-air balloon catheter 1 is inserted into the pulmonary blood vessel 17. In this state, the diameter of the balloon 6 is reduced to a minimum. Then, the balloon 6 is inserted into the lung enterprise tube 17. The radio-frequency hot-air balloon guide 15 is operated to place the balloon 6 near the target tissues 18. Then, as shown in FIG. 4 (b), the inner rod 3 is withdrawn, and a contrast agent and a physiological salt solution are supplied into the balloon 6 through the side branch officer 51 to inflate the balloon 6. Since the pre-rotation sleeve 20 is moved toward the post-rotation sleeve 21, the electrode wires 8a are bent into an arc shape. Thereby, the radio frequency electrode 8 is extended inside the balloon 6 in a basket shape 20. The radio-frequency hot-air balloon catheter i is continuously operated to bring the balloon 6 into contact with the target tissue μ. After that, the motor 38 is started to drive the rotating basic sleeve 23 for rotation by the reduction gear 35. The turning force of the rotating basic sleeve 23 is transmitted to the rotating sleeve 16 584552 by the spiral lead 10 extending through the catheter 4 and the invention description 21 °. Therefore, it extends into the balloon 6 in the shape of a basket. The RF electrode 8 is rotated to agitate the liquid filled in the balloon 6. ίο 15 Subsequently, the radio frequency generator 40 applies a radio frequency current, such as a radio frequency motor of 13.56MΗζ, to the counter electrode ^ attached to the back of the patient, and is connected to the radio frequency hot air balloon catheter i in a basket shape. Stretch the contact of the RF electrode between 25%. A radio frequency current flows through the brush 29 to make contact with the contact% 25. Therefore, the balloon 6 and the groups that are in contact with the balloon 6 are heated by a capacitor type heating with radio frequency dielectric heating attached. Regarding the temperature of the upper area of the balloon 6, if the liquid contained in the balloon 6 is not moved, it will be higher than the lower area of the balloon 6 due to convection, and the temperature of the liquid contained in the balloon 6 will be higher. The distribution can be evenly hooked by turning the liquid by the rotating RF electrode 8 extending in a blue shape. If the radio frequency electrode 8 is not aligned with the balloon 6 and is held in the balloon 6, the tissues 18 will be heated irregularly. Since the radio frequency electrode 8 is heated, a uniform RF electric field can be generated around the radio frequency electrode 8, and the balloon 6 and the tissues 18 are uniformly heated by radio frequency heating. The portion of the balloon 6 near the rotating sleeves 20 and 21 for the electrode wires to gather around has a tendency to overheat. Such overheating can be avoided by forming the sleeves 20 and 21 with a material having a small dielectric constant, such as resin or ceramic material, and / or by covering the electrode wires with resin, And / or avoid it by circulating cooling water through the inner rod 3. Therefore, the pulmonary blood vessel 17 can be electrically isolated by cauterizing the tissue 18 of the atrium 19 around the annular portion of the pulmonary enterprise tube 17 for the safe treatment of fibrous facial movements to the patient. 17 584552 Description of the invention ~ The radio-frequency hot-air balloon catheter 1 according to the second embodiment of the present invention is described in detail later. The radio-frequency hot-air balloon catheter package 3 is used to circulate the liquid in the balloon 6 to make the liquid temperature distribution uniform. A portion of the inner cymbal 3 extending inside the balloon 6 is provided with a number of small nozzles. The circulation 66 is used to keep the liquid being supplied in the inner tube 3, such as the liquid of 37 c, and a liquid supply device 62. 15 A liquid of a predetermined temperature controlled by the temperature controller 66 is supplied into the inner rod 3, and the liquid sprayed through the small nozzles 64 can be sucked through the annular space between the inner rod 3 and the -outer rod 2. The balloon 6 is inside. When inflated, the balloon 6 has an -ellipsoidal shape. A radio frequency electrode 8 is spirally wound around a portion of the inner rod 3 extending inside the balloon 6. The radio frequency electrode 8 is connected to the radio frequency by-lead H)! The temperature of the liquid contained in 4Ge contained in the balloon 6 is measured by a thermocouple 12 and monitored in a similar manner to the first embodiment described above, and the RF energy used to supply the RF electrode 8 is measured according to the amount Measured temperature to control. As shown in FIG. 5, the temperature controller 66 is controlled to, for example, 37 t: one of the circulating liquid 70 is heated at 44 ° C., while the circulating liquid 70 flows through the inner rod 3 and extends inside the balloon 6. Partially ejected through the small pouts 64 and flows into the balloon 6. The temperature of the circulating liquid 20 70 sprayed into the balloon 6 dropped to 43.5 ° C and further dropped to 43 ° C when the circulating liquid 70 reached the front end of the outer rod 2. Thereby, the circulating liquid 70 is circulated by the circulation system 60 so that the liquid contained in the balloon 6 is uniformly maintained at about 43.5 ° C. In the following, the radio frequency hot air balloon catheter 1 as shown in Fig. 5 is as shown in Fig. 7. The radio frequency hot air balloon catheter 1 shown in Fig. 5 applies 18 584552 玖, the description of the invention to the medical treatment of the arterial application site. 5 10 15 The balloon 6 of the radio-frequency hot-air balloon catheter 1 is compressed, and the radio-frequency hot-air balloon catheter 1 is inserted through the femoral artery 68 inside the diseased part of the carotid artery, as shown in Fig. 6 (a). Then, a contrast agent and a physiological salt solution are supplied to the balloon ㈣ through the branch f 51 on the outer rod 2 of the attachment material. Therefore, the balloon 6 is inflated to stretch the narrow part of the diseased part ⑼ as shown in FIG. In this state, an RF voltage of 13.3; 6mHz is applied across the RF electrode 8 and the counter electrode 53 attached to the back of the patient. ^ The circulation system 60 supplies a circulating liquid% such as 3rc to the inner cavity of "Hai Nei # 3" by pressurization. The circulating liquid claw heated by radio frequency is sprayed through the small nozzles 64 and sprayed into the balloon 6. The circulating liquid% flows through the balloon 6 'to make the temperature distribution inside the balloon 6 uniform, and is discharged through the inner cavity of the outer rod 2. When the balloon 6 is maintained at 43 ° C for 20 minutes or more, inflammatory cells or proliferating smooth muscle cells in the atherosclerotic lesion site 68 of the carotid artery will ride on ap_is, and The atherosclerotic lesion 68 can be stabilized. After that, the balloon 6 is compressed and the radio-frequency hot-air balloon catheter is withdrawn from the femoral artery. This radio frequency hot air balloon catheter! It can heat the diseased area 68 m evenly at an optimal temperature. Therefore, the 20th place of carotid artery atherosclerotic lesions 68 can pass the plan of these inflammatory cells or hypertrophic smooth muscle cells, ie the disturbed factor. Apoptosis can be stabilized by heating the carotid atherosclerotic lesion 6W 43 50c for 20 minutes or longer without affecting normal tissues, such as Endothelium. . Radiofrequency hot air balloon catheters can be applied to hyperthermia of cancer 19 584552 (Hyperthermia). It turns out that cancer cells can be controlled or eradicated by heating them at 43.5 ° C for 20 minutes or more. As shown in FIG. 8, a radio-frequency hot-air balloon catheter 1 according to a third embodiment of the present invention is shown. The radio-frequency hot-air balloon catheter 1 includes a balloon 6 and a 5 agitating device 80 for agitating and containing the balloon 6. To make the temperature distribution of the liquid uniform. The agitating device 80 includes a connecting tube 82 connected to an outer rod 2 to be opened to form an annular channel 83 defined by the outer rod 2, and an inner rod 3 extending through the outer rod 2 and a vibration generator 81, such as A vibration generates a 10-plate pump to apply a vibration force to fill the liquid in the annular channel 83. The connecting tube 82 communicates with the balloon 6 through the annular passage 83. A vibration force 86, such as about 1 Hz, generated by the vibration generator 81 spreads through the liquid filling the connecting tube 82 and the annular channel 83. Therefore, the liquid contained in the balloon 6 will generate thirst 85 due to the interaction between the actuated liquid and gravity. 15 These thirsts actuate the liquid through a variable direction during operation, so that the temperature distribution of the liquid contained in the balloon 6 can be homogenized. Thereby, the pulveroma formed in these tissues 68 can be homogenously heated at an optimal temperature. Similar to the RF electrode 8 shown in Fig. 5, one of the RF electrodes 8 spirally coiled around the inner rod 3 is used for RF heating. 20 # When the balloon 6 is formed of a suitable flexible material, the vibration force 86 'generated by the vibration generator 81 can generate a moderate vortex in the liquid contained in the balloon 6. It can be known from the foregoing that the radio-frequency hot-air balloon catheter of the present invention can heat the tissue in contact with the balloon by-

20 584552 玖、發明說明 全形成一貫穿三維壞死表層,不會因血栓形成或組織燒焦 而導致潰瘍。因此,可安全且確實地達到心律不整的治療 ’例如自肺靜脈及其毛孔經由肺靜脈的隔離,以心臟期外 收縮所激發的心房纖維顫動。 5 由於該等組織可被於一最佳溫度均勻地加熱,因此藉 加熱一動脈硬化部位於一預定溫度以使不穩定因子的内之 發炎性細胞或增生平滑肌細胞進行計劃性細胞凋亡 (apotosis),可穩定該動脈硬化部,而不會影響正常組織, 例如内皮。 10 儘官本發明已以特定程度的特質詳細說明其較佳實施 例,很明顯地其中可作許多變更及變化。 舉例來說,純佳實_巾該反電極53錢著於病人 身體的表面上。然而’該反電極53所設置的位置並不偈限 於病人身體表面上。該反電極53亦可設置於該氣球的壁部 15或該氣球内部’或者該反電極53亦可設置於鄰近該氣球的 位置處。 可知本發明可以不同於上述特定說明的方式 實施,而不致脫離其範圍及精神。 I!圖式簡單說明】 2〇 ,第1圖是根據本發明第-實施例的射頻式熱氣球導管 /前部之不意透視圖; Θ /射頻式熱氣料管連續於第1圖所示的射 頻麻球導管前部之後部之示意透視圖; 弟3圖是用以說明該射頻式熱氣球導管於應用於作心 21 584552 玖、發明說明 房纖維顫動治療的肺血管之電隔離的操作之示意圖; 第4(a)及4(b)圖是一氣球導管的示意圖,分別是於該 氣球被壓縮用以插入於肺血管内的狀態,及於該氣球膨脹 以與一目標器官損害部接觸的狀態; 5 第5圖是根據本發明第二實施例的射頻式熱氣球導管 之不意透視圖,20 584552 发明 、 Explanation of the invention A full-three-dimensional necrotic surface is formed, which will not cause ulcers due to thrombosis or tissue burning. Therefore, the treatment of arrhythmia can be achieved safely and surely, for example, atrial fibrillation induced by extracardiac contraction from the isolation of the pulmonary veins and their pores through the pulmonary veins. 5 Because these tissues can be uniformly heated at an optimal temperature, planned heating of inflammatory cells or proliferating smooth muscle cells within unstable factors by heating an arteriosclerosis at a predetermined temperature (apotosis) ), Can stabilize the arteriosclerosis without affecting normal tissues, such as the endothelium. 10 BEST OF THE INVENTION The present invention has been described in detail with reference to its preferred embodiments to a certain degree of particularity, and it is apparent that many changes and modifications can be made therein. For example, the pure counter electrode 53 is placed on the surface of the patient's body. However, the position where the counter electrode 53 is provided is not limited to the surface of the patient's body. The counter electrode 53 may also be provided at the wall portion 15 of the balloon or inside the balloon 'or the counter electrode 53 may be provided at a position adjacent to the balloon. It is understood that the present invention may be implemented in a manner different from the specific description above without departing from the scope and spirit thereof. I! Brief description of the diagram] 20, Fig. 1 is an unintended perspective view of a radio-frequency hot-air balloon catheter / front according to the first embodiment of the present invention; Θ / radio-frequency hot gas pipe is continuously shown in Fig. 1 The schematic perspective view of the front and back of the radiofrequency hemp catheter; Figure 3 is used to illustrate the operation of the radiofrequency hot air balloon catheter in the application of heart isolation 21 584552 发明, the invention illustrates the electrical isolation of pulmonary blood vessels for atrial fibrillation treatment Schematic diagrams; Figures 4 (a) and 4 (b) are schematic diagrams of a balloon catheter when the balloon is compressed for insertion into a pulmonary vessel, and when the balloon is inflated to contact a target organ lesion 5; Figure 5 is an unintended perspective view of a radio-frequency hot-air balloon catheter according to a second embodiment of the present invention,

第6(a)及6(b)圖是第5圖所示該射頻式熱氣球導管的 示意圖,分別是於一氣球被壓縮用以插入於股動脈内的狀 態,及於該氣球膨脹以與一目標組織鄰近處接觸的狀態; 10 第7圖是用以說明一熱氣球導管用於治療動脈硬化症 的使用之示意圖;及 第8圖是根據本發明第三實施例的射頻式熱氣球導管 之部分圖。 【圖式之主要元件代表符號表】Figures 6 (a) and 6 (b) are schematic diagrams of the radio-frequency hot-air balloon catheter shown in Figure 5, respectively, when a balloon is compressed for insertion into the femoral artery, and when the balloon is inflated to communicate with A state of contact in the vicinity of a target tissue; FIG. 7 is a schematic diagram illustrating the use of a hot-air balloon catheter for treating arteriosclerosis; and FIG. 8 is a radio-frequency hot-air balloon catheter according to a third embodiment of the present invention Part of the figure. [Representation of the main components of the diagram]

1…射頻式熱氣球導管 16…導線 2…外桿 17…肺血管 3…内桿 17冱".毛孑匕 4…導管 18…目標組織 6…氣球 19…心房 8…射頻電極 20···轉動前套管 8a…電極線. 21…轉動後套管 10…引線 23…轉動基本套管 12…熱電偶 24…環體 14…攪動裝置 25…接觸環 22 584552 玖、發明說明 27,28...0 型環 70…循環液體 29…電刷 80…攪動裝置 31,33…外螺紋 81…震動產生器 32,34…螺帽 82…連接管 35…減速齒輪 83…環形通道 36,37…齒輪 85…漩渦 38…馬達 86…震動力 40···射頻產生器 42…溫度計 5l···分支管 53…反電極 60···循環系統 62…液體供應裝置 64…噴嘴 66…溫度控制器 68…害病部位1 ... radio frequency hot air balloon catheter 16 ... lead wire 2 ... outer rod 17 ... pulmonary blood vessel 3 ... inner rod 17quot ". Mao Mao 4 ... catheter 18 ... target tissue 6 ... balloon 19 ... atrium 8 ... RF electrode 20 · Turn the front sleeve 8a ... electrode wire. 21 ... turn the rear sleeve 10 ... lead 23 ... turn the basic sleeve 12 ... thermocouple 24 ... ring body 14 ... stirring device 25 ... contact ring 22 584552 玖, invention description 27,28 ... 0 ring 70 ... circulating liquid 29 ... brush 80 ... stirring device 31,33 ... external thread 81 ... vibration generator 32,34 ... nut 82 ... connection tube 35 ... reduction gear 83 ... ring channel 36,37 ... gear 85 ... vortex 38 ... motor 86 ... vibration force 40 ... RF generator 42 ... thermometer 5l ... branch tube 53 ... counter electrode 60 ... circulation system 62 ... liquid supply device 64 ... nozzle 66 ... temperature control Device 68 ... Diseased area

23twenty three

Claims (1)

拾、申請專利範圍 1·一種射頻式熱氣球導管,包括·· 一導管,由一外桿及一内桿 忤所構成,該内桿延伸穿滿 該外桿以可相對於該外桿滑動; k 一膨脹氣球,可膨脹以與一 /、目^裔宫損害部相接觸且 設置於該外桿及該内桿的個別端部之間; -射頻電極,用以與一反電極結合作射頻能量供應, 延伸於喊球之-壁部内或該氣球内部,該反電極設置於 一預定位置; 一引線,電連接於該射頻電極; 10 ’皿度感心,可感測容納於該氣球内的液體之溫度 :及 -溫度分布均勾化裝置,用以使容納於該氣球内的液 體之溫度分布均句化。 2.如申專利粑圍帛丨項所述之射頻式減球導管,其中 該溫度分布均句化裝置是一授動裝置,用以授動容納於該 氣球内的液體。 3·如申μ專利範圍第2項所述之射頻式熱氣球導管,進一 步包括: 一轉動前套管,放置於該内桿之一前端部上,以繞該 2〇 導管的軸心轉動; 一轉動後套管,放置於該外桿之一前端部上,以繞該 導管的軸心轉動;及 一轉動基本套管,持住該引線以致於可供應射頻能量 於該引線且該引線可被轉動; 24 584552 拾、申請專利範圍 其中該射頻電極包含數電極線,以相互平行延伸於該 轉動前套管與該轉動後套管之間,及 °亥擾動裝置包含一旋轉驅動裝置,用以驅動該射頻電 極4轉動則套管、該轉動後套管、該引線及該轉動基本 5 套管以使其轉動。 4·如申μ專·圍帛3項所述之射頻式熱氣球導管,其中 4射頻電極包含數電極線以相互平行連接於該轉動前套管 及该轉動後套管。 5·如申叫專㈣圍第4項所述之射頻式熱氣球導管,其中 10开> 成違射頻電極之該等線性延伸電極線可被彎曲成一圓弧 形狀,以當該外桿及該内桿相互轴向移動以使該氣球膨脈 時可沿該氣球的一内表面延伸。 6.如申請專利範圍第3項所述之射頻式熱氣球導管,其令 該引線螺旋盤繞,且該旋轉驅動裝置轉動該引線以轉動該 15 射頻電極。 / 巧尸/7¾之射頻式熱氣球導管,其 該旋轉驅動裝置驅動該轉動前套管、該轉動後套管、該 20 線及該轉動基本套管以使其以相反方向交互轉動,且藉; 各該等相反方向敎的轉數,於轉動該轉動前套管、^ ㈣套管、該引線及該轉動基本套管之後改變該轉動: 官、該轉動後套管、該m該轉動基本套管之轉動方虎 其tPatent application scope 1. A radio-frequency hot air balloon catheter, including a catheter composed of an outer rod and an inner rod, the inner rod extending through the outer rod to be slidable relative to the outer rod; k an inflatable balloon that can be inflated to make contact with a damaged part of the palace and is placed between the outer rod and the individual ends of the inner rod;-a radio frequency electrode for cooperating with a counter electrode for radio frequency The energy supply extends inside the wall of the shouting ball or inside the balloon, and the counter electrode is arranged at a predetermined position; a lead wire is electrically connected to the radio frequency electrode; 10 ′ is sensed, and the sensor contained in the balloon can be sensed. The temperature of the liquid: and-the temperature distribution uniformization device is used to make the temperature distribution of the liquid contained in the balloon uniform. 2. The radio-frequency type ball reduction catheter as described in the item of the patent application, wherein the temperature distribution homogenization device is an actuating device for actuating the liquid contained in the balloon. 3. The radio-frequency hot-air balloon catheter as described in item 2 of the patent application patent, further comprising: a rotating front sleeve placed on a front end portion of the inner rod to rotate around the axis of the 20 catheter; A rotating sleeve is placed on a front end of the outer rod to rotate around the axis of the catheter; and a basic sleeve is rotated to hold the lead so that radio frequency energy can be supplied to the lead and the lead can It is rotated; 24 584552. The scope of the patent application is that the radio frequency electrode includes several electrode wires to extend parallel to each other between the pre-rotating sleeve and the post-rotating sleeve, and the disturbance device includes a rotary driving device. In order to drive the RF electrode 4 to rotate, the sleeve, the sleeve after the rotation, the lead wire and the rotation basically 5 sleeve are caused to rotate. 4. The radio-frequency hot-air balloon catheter as described in item 3 of Shen μ College, wherein 4 radio-frequency electrodes include several electrode wires to be connected in parallel to the pre-rotating sleeve and the post-rotating sleeve. 5. The radio-frequency hot-air balloon catheter as described in item 4 of the patent, in which the 10 extensions > the linearly extending electrode wires that violate the radio frequency electrode can be bent into an arc shape so that when the outer rod and The inner rods move axially relative to each other so that the balloon can extend along an inner surface of the balloon when the balloon is inflated. 6. The radio-frequency hot-air balloon catheter according to item 3 of the scope of patent application, wherein the lead wire is spirally wound, and the rotary driving device rotates the lead wire to rotate the 15 RF electrode. / Qiao Shi / 7¾ radio frequency hot air balloon catheter, the rotary driving device drives the pre-rotating sleeve, the post-rotating sleeve, the 20 wire and the turning basic sleeve to rotate in opposite directions alternately, and by The number of rotations of each of the opposite directions, the rotation is changed after rotating the pre-rotation sleeve, ^ ^ sleeve, the lead and the rotation basic sleeve: official, the rotation sleeve, the m basic rotation Rotation of the casing 如申請專利範菌第2項所述之射頻式熱氣球導管 該攪動裝置包含: 吕 25 拾、申請專利範圍 連接官,連接於該外桿,藉一由該外桿與該内桿界 &之通道而與該氣球連通;及 展動產生裝置,用以將震動力施予填滿於該連接管 及該通道之液體。 5 9·如中請專利範圍帛8項所述之射頻式熱氣球導管,其令 該震動產生裝置將震動力施予填滿於該連接管及該通道之 液體,以致於使容納於該氣球内之液體中產生旋渦。 10·如申凊專利範圍第1項所述之射頻式熱氣球導管,其中 該溫度分布均勻化裝置是一循環裝置,用以循環容納於該 1〇氣球内的液體,以致於使容納於該氣球内的液體中溫度分 布均勻化。 U·如申請專利範圍第10項所述之射頻式熱氣球導管,其 中該内桿延伸於該氣球内之部位設置有數小喷嘴,及 該循環裝置包含一液體供應裝置,可供應該液體至該 15 内杯内以經由該等小喷嘴噴射該液體且可經由該外桿及該 内桿所界定之該通道吸取噴射於該氣球内之液體。 12·如申請專利範圍第8項至第10項任一項所述之射頻式 熱氣球導管,其中該射頻電極是螺旋盤繞於該内桿於該氣 球内部之一部位。 20 13 ·如申請專利範圍第1項所述之射頻式熱氣球導管,其中 s亥氣球是以抗血栓形成(antithrombogenic)的且熱阻性及挽 性樹脂所形成。 14·如申請專利範圍第1項所述之射頻式熱氣球導管,其中 該預定位置是於病人身體的一位置,且該反電極是附著於 26 584552 拾、申請專利範圍 病人身體上。 15.如申請專利範圍第1項所述之射頻式熱氣球導管,其中 該預定位置是於該氣球的一壁部内或該氣球内部之一位置 〇 5 16.如申請專利範圍第1項所述之射頻式熱氣球導管,其中 該預定位置是鄰近於該氣球之一位置。 % 27The radio frequency hot air balloon catheter according to item 2 of the patent application, the agitating device comprises: Lu 25, a patent application scope connection officer connected to the outer rod, and by means of the outer rod and the inner rod boundary & The passage communicates with the balloon; and a motion generating device for applying a vibration force to the liquid filling the connecting pipe and the passage. 5 9 · The radio frequency hot air balloon catheter described in item 8 of the Chinese patent, which causes the vibration generating device to apply a vibration force to the liquid filling the connecting tube and the channel, so that the balloon is accommodated in the balloon Vortex is generated in the liquid inside. 10. The radio-frequency hot-air balloon catheter as described in item 1 of the scope of the patent of Shenying, wherein the temperature distribution homogenizing device is a circulation device for circulating the liquid contained in the 10 balloon, so that the liquid contained in the balloon The temperature distribution in the liquid in the balloon is uniform. U. The radio-frequency hot-air balloon catheter as described in item 10 of the scope of the patent application, wherein the nozzle is provided with a number of small nozzles at the portion where the inner rod extends, and the circulation device includes a liquid supply device for supplying liquid to the 15 In the inner cup, the liquid is sprayed through the small nozzles, and the liquid sprayed into the balloon can be sucked through the outer rod and the channel defined by the inner rod. 12. The radio-frequency hot-air balloon catheter according to any one of claims 8 to 10 in the scope of the patent application, wherein the radio frequency electrode is spirally coiled around the inner rod at a part inside the balloon. 20 13 · The radio-frequency hot-air balloon catheter according to item 1 of the scope of patent application, wherein the sah balloon is made of antithrombogenic and thermally resistant and pudding resin. 14. The radio-frequency hot-air balloon catheter according to item 1 of the scope of patent application, wherein the predetermined position is a position on the patient's body, and the counter electrode is attached to the body of the patient applying for patent scope. 15. The radio-frequency hot-air balloon catheter according to item 1 in the scope of patent application, wherein the predetermined position is a position in a wall portion of the balloon or inside the balloon. 05. According to item 1 in the scope of patent application The radio-frequency hot-air balloon catheter, wherein the predetermined position is a position adjacent to the balloon. % 27
TW92103941A 2001-09-28 2003-02-25 Radiofrequency thermal balloon catheter TW584552B (en)

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DE102010032932A1 (en) * 2010-07-30 2012-02-02 Arne Briest Catheter used in cryosurgery, has expandable container portion with several bars in which a pair of electrodes or one electrode is arranged, and several spacers which are moved in catheter and electrically connected with electrodes
US10485609B2 (en) * 2016-10-18 2019-11-26 Acclarent, Inc. Dilation balloon with RF energy delivery feature

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